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journal of dentistry 41 (2013) 436442

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Marginal quality of posterior microhybrid resin composite


restorations applied using two polymerisation protocols:
5-year randomised split mouth trial
Nicola Barabanti a, Massimo Gagliani b, Jean-Francois Roulet c, Tiziano Testori d,
Mutlu Ozcan e,*, Antonio Cerutti a
a

Department of Fixed and Removable Prosthodontics, University of Brescia, Brescia, Italy


Department of Fixed and Removable Prosthodontics, University of Milan, Milan, Italy
c
Department of Restorative Dental Sciences, College of Dentistry, University of Florida, Gainsville, USA
d
Section of Implant Dentistry and Oral Rehabilitation Department of Odontology, Galeazzi Institute, IRCCS, University of Milan, Milan, Italy
e
Dental Materials Unit, Center for Dental and Oral Medicine, Clinic for Fixed and Removable Prosthodontics and Dental Materials Science,
Zurich, Switzerland
b

article info

abstract

Article history:

Objectives: This randomised, split-mouth clinical study evaluated the marginal quality of

Received 9 August 2012

direct Class I and Class II restorations made of microhybrid composite and applied using two

Received in revised form

polymerisation protocols, using two margin evaluation criteria.

15 February 2013

Methods: A total of 50 patients (mean age: 33 years) received 100 direct Class I or Class II

Accepted 16 February 2013

restorations in premolars or molars. Three calibrated operators made the restorations. After
conditioning the tooth with 2-step etch-and-rinse adhesive, restorations were made incrementally using microhybrid composite (Tetric EvoCeram). Each layer was polymerised using

Keywords:

a polymerisation device operated either at regular mode (600650 mW/cm2 for 20 s) (RM) or

Clinical study

high-power (12001300 mW/cm2 for 10 s) mode (HPM). Two independent calibrated opera-

Composite

tors evaluated the restorations 1 week after restoration placement (baseline), at 6 months

Class I and II restorations

and thereafter annually up to 5 years using modified USPHS and SQUACE criteria. Data were

Marginal quality

analyzed using MannWhitney U-test (a = 0.05).

SQUACE

Results: Alfa scores (USPHS) for marginal adaptation (86% and 88% for RM and HPM,

Polymerisation

respectively) and marginal discoloration (88% and 88%, for RM and HPM, respectively)

RCT

did not show significant differences between the two-polymerisation protocols ( p > 0.05).

USPHS

Alfa scores (SQUACE) for marginal adaptation (88% and 88% for RM and HPM, respectively)
and marginal discoloration (94% and 94%, for RM and HPM, respectively) were also not
significantly different at 5th year ( p >0.05).
Conclusion: Regular and high-power polymerisation protocols had no influence on the
marginal quality of the microhybrid composite tested up to 5 years. Both modified USPHS
and SQUACE criteria confirmed that regardless of the polymerisation mode, marginal
quality of the restorations deteriorated compared to baseline.
# 2013 Elsevier Ltd. All rights reserved.

* Corresponding author at: Head of Dental Materials Unit, University of Zurich, Center for Dental and Oral Medicine, Clinic for Fixed and
Removable Prosthodontics and Dental Materials Science, Plattenstrasse 11, CH-8032, Zurich, Switzerland. Tel.: +41 44 63 45600;
fax: +41 44 63 44305.
zcan).
E-mail address: mutluozcan@hotmail.com (M. O
0300-5712/$ see front matter # 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.jdent.2013.02.009

437

journal of dentistry 41 (2013) 436442

1.

Introduction

The use of resin composite (hereon: composite) materials for


restoring missing dental tissues in a minimal invasive fashion
is an integral part of routine restorative dentistry due to the
improvement in adhesive systems, polymerisation devices
and physical and mechanical properties of the resin systems.
Margin continuity and discloration due to microleakage
has been of interest since the introduction of composite
materials and adhesive resins. The presence of marginal gaps
between the restorative material, in particular between
amalgam and tooth structure, have shown conflicting association with the presence of secondary caries activity.14
Similarly, no clinical evidence exists to support the concept
that microleakage leads to secondary caries but it can be
considered a predisposing factor or a predictor5 that is strongly
influenced by the photo-polymerisation process.6
In current dental practice, composite restorative materials
are usually photo-polymerised. Polymerisation is a complex
operation where many factors may influence the outcome.7
The highest possible polymerisation degree ensures the
quality of the resin-based materials and contributes to the
longevity of a composite restoration.8 Shrinkage behaviour is
influenced by the photo-polymerisation technique, the intensity of the irradiation, the photo-initiator type and content,
and the elasticity modulus of the composite.9,10 These factors,
as well as cavity size and c-factor,11 may also influence the
marginal features of a composite restoration.11,12
With the progress in light emitting diode (LED) technology,
manufacturers currently offer more powerful polymerisation
devices that allow quicker polymerisation.1316 These
improvements follow the total energy concept,17 but are
challenged by stress build-up at the composite interfaces.11
Especially in the initial phase, a slow polymerisation allows
the composite to compensate for volume reduction by flowing
before the gel point is reached.18 Thus, less stress is generated
at the interface, yielding better margin quality.19 However, this
process is strongly influenced by the polymerisation shrinkage
and the modulus of elasticity of the composite.20 Furthermore,
both of these factors are influenced by the monomer matrix
composition and filler load of the composite.21 In addition,
margin quality of composite restorations are dictated by the
polymerisation stress that works also as a function of the type
of adhesive used.21
The United State Public Health Service (USPHS) criteria was
developed by Cvar and Ryge in an attempt to evaluate the
restoration quality in a standardised and reproducible way.22
These criteria have been modified over the years.23 In 2007, a

group of scientists tried to redefine the Ryge criteria so that


they could be adapted to modern clinical situations.20 This
group also described an additional, more sensitive tool for
clinical margin analysis (SQUACE). This method estimated the
proportion of total margin length affected by the relevant
criteria. To the authors best knowledge, the outcome of
USPHS and SQUACE has not been compared in one clinical
study.
The objectives of this study therefore were to compare the
marginal quality of composite restorations employing two
polymerisation protocols, namely regular versus high power,
in a randomised, split-mouth clinical trial using modified
USPHS and SQUACE criteria. The null hypothesis tested was
that marginal adaptation and marginal discolouration of Class
I and II composite restorations would not be affected, by the
polymerisation protocols used.

2.

Materials and methods

2.1.

Study design

The brands, types, manufacturers, chemical compositions and


batch numbers of the materials used in this study are listed in
Table 1.
Modified split-mouth design was employed where the
contralateral teeth of premolar or molars of the same arch
received a Class I or Class II composite restorations according
to Black classification after caries removal. Depending on the
presence of caries, in some cases, while in one arch a premolar
was restored, in the opposite arch a molar was restored.
Randomisation was performed using the flip of a coin for the
choice of the polymerisation protocol.

2.2.

Inclusion and exclusion criteria

Between April-2004 and July-2004, a total of 50 patients aged


between 19 and 46 years old (19 male, 31 female, mean age: 33)
received 100 direct composite restorations. Patients recruited
for this study needed a restoration due to primary decay with
cavity margins in enamel. Before enrolment in the trial, all
patients were provided with a written informed consent form
approved by the ethical committee of the university institutional review board. Information was given to each patient
regarding the alternative treatment options. The inclusion
criteria were as follows: all subjects were required to be at least
18 years old, able to read and sign the informed consent
document, physically and psychologically able to tolerate
conventional restorative procedures, having no active

Table 1 The brand, type, manufacturer, chemical composition and batch numbers of the main materials used in this
study.
Brand

Manufacturer

Chemical composition

Excite

2-step etch-and-rinse
adhesive resin

Type

Ivoclar Vivadent,
Schaan, Liechtenstein

Tetric EvoCeram

Microhybrid composite

Ivoclar Vivadent

Dimethacrylates, alcohol, phosphonic


acid acrylate, HEMA, SiO2, initiators
and stabilisers
bis-GMA, TEGDMA, UDMA
resin 5.2% butandioldimethacrylate,
66.3 v% strontium, aluminium, glass

Batch number
2006103145

RZD032

438

journal of dentistry 41 (2013) 436442

Fig. 1 Number of restorations placed by the operators and the work flow of the clinical study.

periodontal or pulpal diseases, require restorations due to


primary caries in contralateral quadrants with opposing and
adjacent tooth contact, having no restoration in the antagonist, not allergic to resin-based materials, not pregnant or
nursing, willing to return for follow-up examinations as
outlined by the investigators.
Three operators were selected from a pool of possible
volunteer candidates considering their clinical experience.
The patients were randomly assigned to one of three clinicians
working in the same private practice, two of whom were welltrained and experienced in the application of composites (>5
years since graduation) and one had less experience (<5 years
since graduation) (Fig. 1).
The diagnostic procedures required bitewing radiographs
at baseline. After administration of local anaesthesia, the
restorations were placed under rubber dam using minimally
invasive adhesive dentistry principles24,25 with a microhybrid
composite resin (Tetric EvoCeram, Ivoclar Vivadent, Schaan,
Liechtenstein).

2.3.

Tooth preparation and restoration

Magnified loops (4) were used during removal of the decayed


tissues with rotary and hand instruments. Controlled caries
removal was achieved using Caries Detector liquid (Kuraray
Co., Ltd., Tokyo, Japan). The cavities were cleaned with air
water spray and gently air-dried. After etching enamel for 30 s
and dentine for 20 s with 37% phosphoric acid, the cavities
were rinsed for at least 30 s with airwater spray and dried
using suction to leave the dentine moist and shiny. Three
consecutive layers of single-dose adhesive resin (EXCITE,
Ivoclar Vivadent) were applied and photo-polymerised (Astralis 10, SN 018766, Ivoclar Vivadent, light output: 1200 mW/cm2)
for 20 s. Each layer was polymerised using a polymerisation
unit (Astralis 10) operated either at regular mode (650 mW/cm2
for 20 s) (RM) or high-power (1300 mW/cm2 for 10 s) mode
(HPM). The light intensity was considered functional if the

output was 600650 mW/cm2 for RM and 11501250 mW/cm2


for HPM. Randomisation of the polymerisation protocol used
per quadrant and restoration type is presented in Table 2.
Shade was selected, matching the tooth to be restored. For
Class I restorations, composite was applied in approximately
1 mm thick layers using diagonal incremental technique. The
core part of the restoration was built up with opaque dentine
and the external parts in semi-translucent enamel shades.
Inter-proximal sectional matrices (Palodent System, DentsplyCaulk, Milford, DE, USA) were used for Class II restorations. First,
the inter-proximal wall was built up and photo-polymerised.
The matrix was then removed and the cavity was filled using the
incremental technique as described for Class I restorations. All
restorations were polymerised with one polymerisation unit
(Astralis 10, Ivoclar Vivadent). The power output of the unit was
measured with a radiometer (Cure-Rite, Dentsply-Caulk) before
the placement of each restoration.
After the teeth were restored, the intercuspation was
checked in protrusive movements of the mandible. They were
finished with diamond burs (60- and 40-mm grit) and polished
with pointed silicon polishers (Astropol; Ivoclar Vivadent) and
abrasive polishing brushes (Astrobrush). All hygienists were

Table 2 Randomisation of split mouth design for


polymerisation protocol used per quadrant and restoration type. Regular mode (600650 mW/cm2 for 20 s) (RM);
high-power (12001300 mW/cm2 for 10 s) mode (HPM).
Quadrant

Class

Polymerisation protocol

1
1
2
2
3
3
4
4

I
II
I
II
I
II
I
II

RM
HPM
HPM
RM
RM
HPM
HPM
RM

439

journal of dentistry 41 (2013) 436442

Table 3 List of modified United States Public Health


Service (USPHS) criteria used for the clinical evaluations
of the restorations. *Clinically not acceptable, to be
replaced.
Category
Marginal
adaptation

Marginal
discoloration

Score and criteria


a: Restoration is continuous with existing anatomic form, explorer does not catch
b: Explorer catches, no crevice is visible into
which explorer will penetrate
g: Crevice at margin, enamel exposed
d*: Restoration mobile, fractured or missing
a: No discoloration evident
b: Slight staining, can be polished away
g*: Gross staining

instructed not to do any margin adjustments on the restorations involved in this study.

2.4.

Evaluation

Two independent observers other than the operators, who


were blinded to the objectives of this study and calibrated to
80% agreement, performed the evaluations. Both observers
evaluated the restorations independently, according to the
modified United States Public Health Service (USPHS) (Table 3)
and SQUACE criteria (Fig. 2). With the USPHS and SQUACE
criteria, the whole visible and accessible margin length of
every restoration was assessed. In case of disagreement in
scoring, restorations were re-evaluated, a consensus was
reached and this was accepted as the final score. Restorations
were evaluated 1 week after restoration placement (baseline),
at 6 months and thereafter annually up to 5 years. Patients
were instructed to call in case of a failure. Also, digital
photographs were made at baseline and follow-up sessions.

2.5.

Statistical analysis

Statistical analysis was performed using a statistical software


program (SPSS 13.0; SPSS Inc., Chicago, IL, USA). Non-parametric

Fig. 2 Schematic drawing of a Class II composite


restoration. Black line represents the total marginal length
(100%); Redline indicates discoloured margin scored with
USPHS: Score b and SQUACE: Score b corresponding to 20%
of the total marginal length.

Table 4 Distribution of restoration type and location


polymerised using either RM or HPM protocol.

Premolars
Molars
Total

Class I

Class I

Class II

Class II

RM

HPM

RM

HPM

5
20
25

5
20
25

13
12
25

13
12
25

Total
36
64
100

MannWhitney U-test was used to compare the effect of


polymerisation protocol on the USPHS and SQUACE scores
given for the composite restorations. P values less than 0.05 were
considered to be statistically significant in all tests.

3.

Results

Thirty-six restorations were placed on premolars and 64 on


molars (Table 4). In total, 6 recalls (6 months and annual after
baseline) were performed after baseline measurements. No
drop out was experienced with a recall rate of 100% after
5 years.
Secondary caries, endodontic complications, fractures or
chippings were not observed in any of the restored teeth.
At 5th year controls, Alfa scores (USPHS) for marginal
adaptation (86% and 88% for RM and HPM, respectively) and
marginal discoloration (88% and 88%, for RM and HPM,
respectively) did not show significant differences between
the polymerisation protocols ( p > 0.05) (Table 5).
Alfa scores (SQUACE) for marginal adaptation (88% and 88%
for RM and HPM, respectively) and marginal discoloration (94%
and 94%, for RM and HPM, respectively) were also not
significantly different at 5th year ( p > 0.05) (Table 6).
Post-operative sensitivity at baseline was 4% for RM and 2%
for HPM ( p > 0.05) but disappeared at the next follow up.
No significant difference was found between the operators
( p > 0.05).

4.

Discussion

This clinical study compared the marginal quality of Class I


and II composite restorations applied using either regular or
high power polymerisation protocols, in a randomised, splitmouth clinical trial using the modified USPHS and SQUACE
criteria. The overall marginal quality of the microhybrid
composite tested did not show significant differences with
both polymerisation methods, yielding to acceptance of the
null hypotheses.
An analysis with mean observation period of up to 5 years
could be considered medium term follow-up. Although none
of the restorations needed any intervention until the end of
the observation period, which could be considered clinically
outstanding, outcomes of the qualitative features especially at
the margins should be evaluated carefully. The main focus of
this clinical study was on the marginal quality of the
restorations as it could be affected most by the polymerisation
mode.26 However, since one could not exclude polymerisation
affect on colour, surface quality and wear, USPHS criteria were
used for the evaluation of the restorations. A balanced design

440

journal of dentistry 41 (2013) 436442

Table 5 Summaries of modified USPHS evaluations expressed in percentage at baseline and up to final follow-up for the
composite restorations polymerised using RM and HPM protocols.
Criteria
Marginal adaptation

RM

HPM

Marginal discoloration

RM

HPM

a
b
g
d
a
b
g
d
a
b
g
d
a
b
g
d

Baseline

6 months

1 year

2 years

3 years

4 years

5 years

94
6
0
0
94
6
0
0
98
2
0
0
100
0
0
0

94
6
0
0
94
6
0
0
98
2
0
0
100
0
0
0

94
6
0
0
94
6
0
0
98
2
0
0
98
2
0
0

92
18
0
0
94
6
0
0
98
2
0
0
98
2
0
0

88
12
0
0
90
10
0
0
94
6
0
0
94
6
0
0

84
16
0
0
88
12
0
0
92
18
0
0
90
10
0
0

86
14
0
0
88
12
0
0
88
12
0
0
88
12
0
0

Table 6 Summaries of SQUACE results expressed in percentage at baseline and up to final follow-up for the composite
restorations polymerised using RM and HPM protocols. Extension of the defect covering a) <10%, b) 1020%, c) 2030%, d)
3040%, e) 4050% and f) >50% of total restoration area.

Marginal adaptation

RM

HPM

Marginal discoloration

RM

HPM

a
b
g
d
a
b
g
d
a
b
g
d
a
b
g
d

Baseline

6 Months

94
4(a)2(b)
0
0
88
10(a)2(b)
0
0
98
2(a)
0
0
98
2(a)
0
0

94
4(a)2(b)
0
0
88
10(a)2(b)
0
0
98
2(a)
0
0
98
2(a)
0
0

was employed regarding the operators and the polymerisation


mode variables. The criteria of margin adaptation and margin
discoloration were additionally analyzed with a semi-qualitative method, SQUACE.
The major experimental variable, polymerisation protocol
(low power, long duration versus high power, short duration),
has direct consequences on the time needed for the completion of an incrementally built up direct composite restorations
since polymerisation protocol is defined according to the total
energy concept (time  energy = constant).27 All cervical
margins of Class II restorations had margins in enamel. In
order to reduce the potential confounding variables, hand
instruments were used to finish these margins. The incremental layering technique was used to minimise the polymerisation shrinkage.11,12,28,29
After 5 years of follow up, no fracture or chipping was
observed. Mechanical and physical properties of the material
play a significant role in clinical performance.29 In a review of
clinical studies performed between 1990 and 2003, Manhart
et al.30 reported annual failure rates of 1.7% (median) and

1 year

2 years

3 years

4 years

5 years

92
4(a)4(b)
0
0
88
10(a)2(b)
0
0
96
4(a)
0
0
96
4(a)
0
0

92
4(a)4(b)
0
0
88
10(a)2(b)
0
0
94
6(a)
0
0
94
6(a)
0
0

90
6(a)4(b)
0
0
88
8(a)4(b)
0
0
94
6(a)
0
0
94
6(a)
0
0

90
6(a)4(b)
0
0
88
8(a)4(b)
0
0
94
6(a)
0
0
94
6(a)
0
0

88
8(a)4(b)
0
0
88
8(a)4(b)
0
0
94
6(a)
0
0
94
6(a)
0
0

2  1.8% (mean) for posterior composites. The results of a 3year prospective clinical study on 40 Class I and II restorations
using the same composite as in this study also did not report
any fractures, but 3 caries incidences. In that study, only RM
polymerisation protocol was applied and 38 restorations could
be followed.31 The lack of caries in 5 year follow up in this
study could be also attributed to strict maintenance programme for the practice setting.
Margin quality of the restorations indicated some deterioration compared to the baseline situation. At 5th year controls,
Alfa scores (USPHS) for marginal adaptation decreased from
94% to 86% and Beta scores increased from 6% to 14% using RM
polymerisation method. Similarly, using HPM method, Alfa
scores decreased from 98% to 88% and Beta scores increased
from 2% to 12%. Slight variations in the margin quality
between the studies could be in part due to the application of
adhesive resins or the polymerisation shrinkage of the
composite. The composite used was characterised with low
polymerisation shrinkage (1.6% v/v) and minimal accumulation of polymerisation stresses at the interface.31 In a

journal of dentistry 41 (2013) 436442

previous study, clinical evaluation of three composites (Tetric


Ceram, Tetric EvoCeram and Gradia) for posterior restorations
did not show significant differences between the materials but
marginal change over time was more severe than observed in
this study.31
Although in general marginal quality decreases over time
due to physiological and chemical interactions with the
aggressive oral environment, the onset of degradation could
imply problems associated with the adhesive resin or the
composite. It should also be noted that marginal adaptation
criteria is the sum of marginal opening and sub- and/or overmargination. Hence, baseline and early marginal adaptation
scores may not necessarily score marginal opening or submargination. The percentage of perfect margins (Alfa score)
with both RM and HPM polymerisation methods, gradually
decreased from baseline up to 2nd and 3rd years, indicating that
long-term observations more than 2 or 3 years are essential to
find out the changes in margins of composite restorations.
In this study, both modified USPHS and the semi
quantitative SQUACE methods were used for the evaluation
of margin analysis. At baseline, the results obtained from both
criteria did not differ significantly. Yet, marginal adaptation
with HPM method (88%) was not as good as RM (94%)
polymerised group. Interestingly, the results for Alfa scores
did not change up to 5 years when HPM polymerisation
protocol was used. This could however not be said for
marginal discoloration as both USPHS and SQUACE showed
similar trend in the RM or HPM applied restorations. The
change in the percentage of discoloration was less than
marginal adaptation (Alfa scores) at the 5th year follow up.
Since the length of the margins is dictated by the situation
after caries removal, the measured marginal area may differ.
Moreover, anatomically, the margin length could be smaller in a
premolar than a molar that eventually may affect the scores in
SQUACE. Semi quantitative methods certainly have advantages
as it relates the defect area to the total length. Thus, it can be
stated that it is more advantageous over the more subjective
evaluation method, USPHS. Nonetheless, both methods could
not evaluate the cervical and interproximal areas due to the lack
of visibility. Certainly, regardless of the material used and the
polymerisation technique employed, experience of the operators and their learning curve with a given material would have a
direct impact on the success of the restorations.3234 Thus, the
results obtained may differ if the operators have less experience
with adhesive techniques and incremental build up of resin
composites than those participated in this study. Even in case of
failures, fortunately survival rate of such restorations can be
prolonged using repair techniques.35
In summary, incremental build up of direct composite
applications could be accomplished in a quicker fashion with
high power rapid polymerisation without sacrificing from
marginal adaptation or margin discoloration. Restorations are
under evaluation for long-term follow up.

5.

Conclusions

1. Marginal quality of the microhybrid composite tested up to


5 years was not significantly influenced by the regular and
high-power polymerisation protocols.

441

2. Marginal quality of the restorations decreased at 5th year


compared to baseline situation verified by both modified
USPHS and SQUACE criteria.

Conflict of interest
The authors did not have any commercial interest in any of the
materials used in this study.

Acknowledgements
The authors acknowledge Drs. P.A. Acquaviva and L. Madini
for the evaluation of the restorations and Ivoclar Vivadent,
Schaan, Liechtenstein for generous provision of the adhesive
and composite materials.

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